Advanced Orthopaedics of South Florida – FDA Warning Letter, Dec 21, 2007

This Warning Letter details objectionable conditions observed during an FDA inspection of Advanced Orthopaedics of South Florida from December 13-21, 2007. The inspection assessed compliance with federal regulations for two investigational device studies, [redacted] and [redacted], where Merrill W. Reuter, M.D., Ph.D., acted as both sponsor and investigator.

Serious violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Section 520(g) of the Act were identified. Key deficiencies include: 1. **Failure to obtain FDA and IRB approval:** Both studies were conducted without required approvals. The [redacted] study, initiated in 2002, and the [redacted] study, initiated in 2005, used significant risk devices ([redacted] and [redacted]) for new, uncleared indications without an FDA-approved Investigational Device Exemption (IDE). 2. **Inadequate monitoring and device accountability:** No documentation of monitoring for either study was found, and device accountability records were absent. 3. **Invalid informed consent:** Written consent forms were not IRB-approved, and one subject's consent was not signed and dated prior to device implantation.

Dr. Reuter's response acknowledged failures in obtaining FDA approval, recordkeeping, monitoring, and device accountability,